In some instances, it may be desirable to deploy an endoluminal sleeve or other type of lining within a hollow body organ such as a stomach, intestine, etc. By way of example only, a sleeve may be positioned within a patient's duodenum to separate or bypass at least part of the food flow from the lined portions of the duodenum. In some patients, creating a physical barrier between ingested food and certain regions of the gastrointestinal wall by means of endoluminal sleeves may provide some degree of weight loss and/or treatment of type 2 diabetes. The presence of the barrier may influence or alter signaling (e.g., neural, endocrine, etc.) originating from the intestine and/or improve glycemic control. Contrary to traditional gastric bypass surgery, endoluminal sleeve surgery may be reversed and the sleeve may be removed after achievement of the desired clinical result.
An example of a duodenal sleeve is described in U.S. Pat. No. 7,267,694, entitled “Bariatric Sleeve,” issued Sep. 11, 2007, the disclosure of which is incorporated by reference herein. The proximal end of a flexible, floppy sleeve of impermeable material defining a sleeve lumen is endoscopically deployed and anchored with the help of a barbed stent in the pylorus or in the superior section of the duodenum. The stent is also intended to ensure that the proximal lumen opening of the sleeve remains open. Chyme from the stomach enters the proximal lumen opening of the sleeve and passes through the sleeve lumen to the distal lumen opening. Digestive enzymes secreted in the duodenum pass through the duodenum on the outside of the sleeve, with the sleeve isolating the chyme from the enzymes. The enzymes and the chyme do not mix until the chyme exits from the distal lumen opening of the liner sleeve. In such a way, the efficiency of the process of digestion of the chyme may be diminished, reducing the ability of the gastrointestinal tract to absorb calories from the food. The sudden exposure of chyme to the small intestine (e.g., duodenum, proximal jejunenum, etc.) at the distal end of the barrier may lead to altered signaling from the gastrointestinal system resulting in an improved metabolic response.
Additional examples of endoluminal sleeves are disclosed in U.S. Pat. No. 7,121,283, entitled “Satiation Devices and Methods,” issued Oct. 17, 2006, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,037,344, entitled “Apparatus and Methods for Treatment of Morbid Obesity,” issued May 2, 2006, the disclosure of which is incorporated by reference herein; U.S. Pub. No. 2008/0255678, entitled “Medical Apparatus and Method of Making the Same,” published Oct. 16, 2008, the disclosure of which is incorporated by reference herein; and U.S. Pub. No. 2013/0030350, entitled “Devices and Methods for Anchoring an Endoluminal Sleeve in the GI Tract,” published Jan. 31, 2013, the disclosure of which is incorporated by reference herein. Yet another example of an endoluminal sleeve is the EndoBarrier® by G.I. Dynamics, Inc. of Watertown, Mass.
It should be understood that an endoluminal sleeve positioned in the duodenum and/or elsewhere in the gastrointestinal tract may need to be substantially held in place to enable the sleeve to resist the driving forces of peristalsis in the gastrointestinal tract. The above-noted examples of endoluminal sleeves include various structures and techniques to substantially maintain the position of the sleeve in the gastrointestinal tract. U.S. Pat. No. 7,931,693, entitled “Method and Apparatus for Reducing Obesity,” issued Apr. 26, 2011, the disclosure of which is incorporated by reference herein, discloses other structures and techniques that are used to substantially maintain the position of devices in the gastrointestinal tract. Similarly, U.S. Pub. No. 2009/0187206, entitled “Conformationally-Stabilized Intraluminal Device for Medical Applications,” published Jul. 23, 2009, now U.S. Pat. No. 9,060,835, issused Jun. 23, 2015, the disclosure of which is incorporated by reference herein, also discloses structures and techniques that may be used to substantially maintain the position of devices in the gastrointestinal tract.
While a variety of endoluminal sleeve devices and anchoring devices have been made and used, it is believed that no one prior to the inventor(s) has made or used an invention as described herein.
The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.